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Depressive Disorder, MajorNCT00928980

Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

A study testing Mindfulness Based Cognitive Therapy and Optimal Medical Care in people with Depressive Disorder, Major, run by Radboud University Medical Center at 13 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Mindfulness Based Cognitive Therapy and Optimal Medical Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
317 participants
Where
13 sitesNetherlands
Study dates
May 2009to Jun 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recurrent Major Depressive Episode (at least 3 previous episodes)
  • Treatment with therapeutic dose of antidepressant medication during past six months
  • Currently in full or partial remission

Who cannot join

  • Bipolar disorder (current and previous (hypo)manic episodes)
  • Psychotic disorder (current and previous)
  • Neurological or somatic illness affecting depression or outcome measures
  • Current alcohol or drugs dependency
  • Use of high dosage benzodiazepines (> 2 mg Lorazepam equivalents daily)
  • Recent Electro Convulsive Therapy (< 3 months ago)

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Netherlands13 sites

  • GGZ Noord-Holland-Noord

    Alkmaar, North Holland

  • GGZ Centraal

    Amersfoort, Utrecht, 3800

  • Free University Medical Center and GGZ In Geest

    Amsterdam, North Holland, 1000

  • AMC Amsterdam

    Amsterdam, North Holland, 1100 DD

  • Pro Persona

    Arnhem, Gelderland, 6800

  • Pro Persona

    Ede, Gelderland

  • GGZ Duin- en Bollenstreek

    Katwijk

  • GGZ Rivierduinen - Leiden

    Leiden, South Holland, 2300 AT

  • Leiden University Medical Center

    Leiden, South Holland, 2300 RC

  • Radboud University Nijmegen Medical Center

    Nijmegen, Gelderland, 6525 GC

  • PsyQ

    The Hague, South Holland, 2500

  • Parnassia ACO Zuid

    The Hague, South Holland

  • Pro Persona

    Tiel, Gelderland

Other trials in Netherlands

About this study

Official title: The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression

The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.

Read the detailed description

In the Netherlands, treatment as usual for patients with (recurrent) Major Depressive Disorder consists of maintenance antidepressant medication. Mindfulness-based cognitive therapy (MBCT) is a recently developed psychological intervention that appears to be promising in terms of preventing relapse or recurrence in patients with recurrent depression. It consists of 8 weekly group sessions in which meditation exercises are combined with cognitive therapeutic elements such as identifying negative thoughts and monitoring and scheduling activities.

In this study, the (cost)effectiveness of a) MBCT on its own, b) antidepressant medication on its own and c) the combination of MBCT and antidepressant medication will be investigated in 350 patients with recurrent depression who are currently in remission.

Being tested
Mindfulness Based Cognitive Therapy, Optimal Medical Care
Keywords
Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Cost-effectiveness, Antidepressant medication, Randomized Controlled Trial
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Cognitive TherapyBehavioural

    Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

  • Optimal Medical CareDrug

    Therapeutic dose of antidepressant medication

Study groups in NCT00928980
Study groupRoleWhat they receive
Mindfulness Based Cognitive TherapyExperimentalMindfulness Based Cognitive Therapy and withdrawal of antidepressant medication between the 4th and 5th session, patients being off medication until the end of study period (15 months).
Receives: Behavioral: Mindfulness Based Cognitive Therapy
CombinationExperimentalMindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
Receives: Behavioral: Mindfulness Based Cognitive Therapy; Drug: Optimal Medical Care
Optimal Medical CareActive comparatorTreatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.
Receives: Drug: Optimal Medical Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse/recurrence of Major Depressive Episode

    Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.

    Measured: 3, 6, 9, 12, 15 months

Secondary outcomes (1)

  1. Costs made by consumption of medical care and production loss

    Using prospective calendars and retrospective questionnaires about contacts with health care in the past 3 months (assessed trimonthly) we will estimate the costs of depression health care and the quality of life (selfreport). We will compare the cost-effectiveness ratios between the groups.

    Measured: 3, 6, 9, 12, 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00928980
Sponsor's protocol ID
MFN-2009-2013
Other IDs
80-82310-98-09018, 2008/242
Status last verified
Nov 2020
First submitted
25 Jun 2009
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, Barrett B, Byng R, Evans A, Mullan E, Teasdale JD. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008 Dec;76(6):966-78. doi: 10.1037/a0013786.

    PubMed 19045965

  • Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.

    PubMed 14756612

  • Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.

    PubMed 10965637

  • Huijbers MJ, Wentink C, Simons E, Spijker J, Speckens A. Discontinuing antidepressant medication after mindfulness-based cognitive therapy: a mixed-methods study exploring predictors and outcomes of different discontinuation trajectories, and its facilitators and barriers. BMJ Open. 2020 Nov 11;10(11):e039053. doi: 10.1136/bmjopen-2020-039053.

    PubMed 33177138

  • Huijbers MJ, Spinhoven P, Spijker J, Ruhe HG, van Schaik DJ, van Oppen P, Nolen WA, Ormel J, Kuyken W, van der Wilt GJ, Blom MB, Schene AH, Rogier A, Donders T, Speckens AE. Discontinuation of antidepressant medication after mindfulness-based cognitive therapy for recurrent depression: randomised controlled non-inferiority trial. Br J Psychiatry. 2016 Apr;208(4):366-73. doi: 10.1192/bjp.bp.115.168971. Epub 2016 Feb 18.

    PubMed 26892847

  • Huijbers MJ, Spinhoven P, Spijker J, Ruhe HG, van Schaik DJ, van Oppen P, Nolen WA, Ormel J, Kuyken W, van der Wilt GJ, Blom MB, Schene AH, Donders AR, Speckens AE. Adding mindfulness-based cognitive therapy to maintenance antidepressant medication for prevention of relapse/recurrence in major depressive disorder: Randomised controlled trial. J Affect Disord. 2015 Nov 15;187:54-61. doi: 10.1016/j.jad.2015.08.023. Epub 2015 Aug 18.

    PubMed 26318271

  • Huijbers MJ, Spijker J, Donders AR, van Schaik DJ, van Oppen P, Ruhe HG, Blom MB, Nolen WA, Ormel J, van der Wilt GJ, Kuyken W, Spinhoven P, Speckens AE. Preventing relapse in recurrent depression using mindfulness-based cognitive therapy, antidepressant medication or the combination: trial design and protocol of the MOMENT study. BMC Psychiatry. 2012 Aug 27;12:125. doi: 10.1186/1471-244X-12-125.

    PubMed 22925198

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Cognitive Therapy and Optimal Medical Care in people with Depressive Disorder, Major, run by Radboud University Medical Center at 13 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse/recurrence of Major Depressive Episode (time frame: 3, 6, 9, 12, 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00928980, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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